# The Medicines (Fees Relating to Medicinal Products for Animal Use) (Amendment) Regulations 1991, Schedule


“PART III
FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES
Product licences
1 The fee payable under regulation 5(a) in connection with an application for variation of a product licence—
(a) in the case of a complex application, shall be £1,050;
(b) in any other case—
(i) requiring veterinary, scientific or pharmaceutical assessment–
(aa) for a variation, shall be £315;
(bb) for any other consequential variation to other licences, in identical terms, shall be £105;
(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £105 in respect of each variation;
(iii) where the variation applied for involves the reissue of the product licence in the new name of the company, shall be £105;
(iv) where the product licence relates solely to an emergency vaccine, shall be £30.
Manufacturers' licences
2 The fee payable under regulation 5(a) in connection with an application for variation of a manufacturer’s licence—
(a) in the case of a manufacturer’s licence referred to in paragraph 5(2) of Part II of this Schedule, shall be £85;
(b) in any other case—
(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £325;
(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £90.
Wholesale dealers' licences
3 The fee payable under regulation 5(a) in connection with an application for variation of a wholesale dealer’s licence—
(a) requiring veterinary, scientific or pharmaceutical assessment, shall be £325;
(b) not requiring veterinary, scientific or pharmaceutical assessment, shall be £90.
Animal Test Certificates
4 The fee payable under regulation 5(a) in connection with an application for variation of—
(a) an animal test certificate—
(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £315;
(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £105;
(iii) where the variation applied for involves the reissue of the animal test certificate in the new name of the company, shall be £105; or
(b) an animal test (confirmation of exemption) certificate—
(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £300;
(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £85;
(iii) where the variation applied for involves the reissue of the animal test (confirmation of exemption) certificate in the new name of the company, shall be £85.”

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Source: https://www.legislation.gov.uk/uksi/1991/2063/schedule (the official version)
Page: https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-animal-use-amendment-regulations-1991/schedule
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

